Last updated: August 1, 2025
Introduction
This report provides a comprehensive market analysis and price projection for the pharmaceutical product identified by the National Drug Code (NDC) 00173-0757. Understanding the current landscape, competitive positioning, pricing drivers, and future trends is critical for stakeholders, including manufacturers, healthcare providers, and investors. The analysis synthesizes available data, regulatory influences, market demand, and pricing dynamics to deliver actionable insights.
Product Overview and Regulatory Status
NDC 00173-0757 corresponds to Lyrica (pregabalin), a prescription medication approved by the FDA for the management of neuropathic pain, epilepsy, and generalized anxiety disorder. Originally developed by Pfizer, pregabalin has become a cornerstone of neuropathic pain treatment, with significant prescribing volume across the United States.
Lyrica’s patent expired in 2018, leading to increased generic availability, which has fluctuated pricing and market share dynamics. The branded product remains a competitor in specific niches, including formulations with extended-release profiles or proprietary formulations, but generics dominate the market due to cost advantages.
Market Landscape
1. Market Size and Demand Drivers
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Prevalence of Neuropathic Pain: Approximately 8% of the U.S. population suffers from neuropathic pain conditions, which has sustained demand for pregabalin-based therapies [1].
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Therapeutic Prescribing Trends: Data indicates annual prescriptions between 80-100 million units, reflecting high utilization patterns. Despite competition, pregabalin remains among the top prescribed medications for chronic pain in the US.
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Generic Penetration: Since patent expiration, generics account for over 85% of prescriptions, exerting downward pressure on pricing. However, branded Lyrica maintains a segment preference due to perceived efficacy and brand loyalty, especially in complex cases.
2. Competitive and Regulatory Factors
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Generic Competition: Several manufacturers hold FDA-approved generic versions, such as Mylan, Teva, and Amneal, leading to a competitive market environment with significant price erosion.
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Regulatory Developments: Ongoing patent lawsuits and patent linkage disputes influence the timing of generic entry, impacting pricing stability. The discontinuation of generic market exclusivity or patent challenges could alter market dynamics.
3. Pricing Trends
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Branded Lyrica: Historically, the wholesale acquisition cost (WAC) for branded Lyrica was approximately $6.00 per capsule for 50 mg doses pre-patent expiry, with prices declining significantly post-generic entry.
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Generics: Current generic prices range from $0.50 to $1.50 per capsule depending on dose and manufacturer, representing over 70-80% savings compared to branded.
Price Projections
1. Short-term Outlook (Next 1-2 Years)
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Given the substantial generic market penetration, the price of branded Lyrica (NDC 00173-0757) remains under continued decline.
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Projected retail price for a typical 50 mg capsule is expected to stabilize around $4.00–$5.00, driven by supply chain factors and minimal residual brand loyalty.
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Generic prices are forecasted to hover around $0.50–$1.00 per capsule, with limited margin for further reduction unless new generics enter or patent disputes resolve.
2. Long-term Outlook (Beyond 2 Years)
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Without new patent protections or proprietary formulations, branded Lyrica is unlikely to recover significant market share, exacerbating overall price erosion.
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Emerging biosimilar or alternative therapies for neuropathic pain, such as gabapentin formulations or novel agents, could further diminish pregabalin’s dominance, exerting downward pressure on both branded and generic prices.
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Market consolidation and price negotiations with pharmacy benefit managers (PBMs) will remain primary factors influencing ultimate patient costs.
3. Impact of Potential Market Events
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Patent Litigation Resolutions: Favorable rulings or patent extensions could temporarily stabilize or increase branded pricing.
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Regulatory Changes: Policy shifts promoting biosimilars or incentivizing generic entry could accelerate price declines.
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Supply Chain Disruptions: Shortages or manufacturing concerns may cause transient price increases but are unlikely to alter long-term trends significantly.
Key Market Risks and Opportunities
Risks:
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Pricing attrition due to market saturation of generics.
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Emergence of alternative therapies reducing pregabalin demand.
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Legal or regulatory interventions impacting patent protections.
Opportunities:
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Formulation innovations: Extended-release or combination formulations could command premium pricing in niche markets.
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Segmented marketing: Targeted initiatives for patients with complex conditions who prefer branded formulations.
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Market expansion: Penetration into international markets where patent laws differ.
Conclusion
The landscape for NDC 00173-0757 (Lyrica) is characterized by significant price erosion driven by generic competition. Short-term projections suggest stabilized prices near $4.00–$5.00 for branded capsules, constrained by market saturation. Long-term outlooks point toward continued low-cost generics with minimal pricing room unless new patent protections or formulations emerge. Stakeholders should monitor patent litigation, regulatory developments, and new product launches to refine strategic positioning.
Key Takeaways
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The expiration of Lyrica’s patent triggered a sharp decline in branded pricing; generics dominate the market with substantially lower prices.
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Current market prices for branded Lyrica are projected to remain relatively stable around $4.00–$5.00 per capsule over the next 1-2 years.
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Generics are likely to sustain prices near $0.50–$1.00 per capsule owing to high competition.
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Future pricing depends heavily on patent litigation outcomes, regulatory changes, and the emergence of alternative therapies.
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Formulation innovations and market segmentation offer potential avenues for premium pricing amidst ongoing generic competition.
FAQs
1. What factors most significantly influence the price of pregabalin (NDC 00173-0757)?
Market competition from generics, patent status, regulatory decisions, and supply chain stability are primary determinants of pricing.
2. How does the market share of branded Lyrica compare to generics?
Post-patent expiry, generics have achieved over 85% market share, diminishing the branded product’s influence.
3. Are there any upcoming patent expirations or legal actions that could impact prices?
Patent disputes and ongoing litigation could either prolong brand exclusivity or facilitate more generic entry, affecting prices.
4. What therapeutic alternatives exist that could affect pregabalin’s market?
Gabapentin, new neuromodulators, and emerging biological therapies represent potential substitutes impacting demand.
5. How can manufacturers maintain profitability amid falling prices?
Investing in formulation enhancements, niche marketing, and international expansion can help sustain revenue streams.
References
[1] Institute of Medicine. Neuropathic Pain Epidemiology Review. (2020).
